There has been a marked increase in the use of disposable medical implements, particularly medical delivery or collection implements, such as hypodermic needles/syringes or evacuated blood collection tubes. Typically, such medical implements include piercing elements for administering a medication or withdrawing a fluid. Such piercing elements include, inter alia, pointed needle cannulae or blunt ended cannulae.
Exposure to blood borne pathogens is a recognized hazard by anyone associated with the medical arts. As a result of this recognition, numerous protocols for the use of piercing elements such as needles have been developed and are practiced. The problem of transmission of blood borne pathogens not only exists for the physician, nurse or phlebotomist using the needles, but also for support workers all through the hospital. Since most needles in use today are single-use and disposable, hospital service personnel are at risk from needles that are not properly handled by the users. A definite need has developed for ways to safely and conveniently handle and transport such implements, both during interim use of the implement and after use is completed, so that disposal can be effected while reducing the risk of exposing any person handling the used implements to injury, infection or disease by puncture or contact with a used needle.
In today's medical facilities, then, a wide variety of disposable needle devices are routinely used to administer medication by injection and intravenous ("I.V.") procedures, or for intravenous collection or withdrawal procedures such as blood collection. Either interim the completion of a procedure or once an injection is given, a blood sample dram, or an I.V. needle removed from a patient, both the needle and/or syringe or tube used in the procedure may be contaminated and must be either handled or disposed of in a safe manner. The problem is particularly heightened because competent medical personnel will not normally leave a patient unattended immediately after administering an I.V. procedure in order to search out disposal facilities for the used medical implement. Consequently, while the nurse or physician is attending to the patient, unsheathed contaminated needles have been momentarily placed on bedside tables, the used needles have been placed on the patient's bedding, and bed mattresses have even been used as a type of "pincushion" to temporarily hold the contaminated needle.
The needle use protocols previously mentioned generally dictate in detail when and how a needle will be used and how it should be disposed of. The problem with many protocols for handling needles is that the protocols often require users to perform additional steps in a procedure. With the pressure of time and simple carelessness, certain practices regarding handling of used needles are sometimes disregarded and injuries may occur.
For instance, it has been a practice to break or cut a piercing element such as a needle after use and before transport to ultimate disposal so as to eliminate the sharp end point, thereby reducing the risk of puncture, scratching or other injury which might result from handling. However, the very act of breaking or cutting the needles may expose the medical personnel to accidental puncture during the breaking or cutting operations. In addition, residual medication or blood in the needle or the syringe can splatter onto the person or his clothes, and potentially harmful fumes from the residual medication could be inhaled as a result of the so-called aerosol effect. Furthermore, the blades of the cutting tool might possibly serve as a breeding ground for germs, bacteria and other disease-causing micro-organisms to which an unsuspecting person cutting the needle could be unnecessarily exposed. Recently, an even greater danger has been recognized in connection with the handling and disposal of used needles as well as other sharp medical implements. It is now believed that certain diseases, most notably Hepatitis B, can be transmitted by covert percutaneous--i.e., by merely contacting the contaminated needle or implement.
While the used needle portion of a needle/medical implement combination presents the most significant risk of injury or injection through accidental puncture or scratching of a person's skin, the used implement part may also present a risk of infection. For example, a used implement such as a syringe, a blood collection shield, or the like can contain residual blood or medication which, if exposed to a person's skin, may be absorbed topically (particularly if a cut or break in the skin is present) and may cause a serious internal infection or other reaction. As a result of the foregoing dangers, it is preferred current practice to dispose of such devices intact, without dismantling them.
One contemplated solution lies in disposing of the whole, used piercing element/implement by recapping it before disposal with its original, protective sheath. The contaminated needle point and shaft would thus be isolated against inadvertent contact or puncture until it could be deposited in a disposal unit. Previously, the recapping solution was discouraged because of the inherent risk of accidental puncture if the person was unsuccessful in re-inserting the needle into the sheath. While the U.S. Occupational Safety and Health Administration ("OSHA") has stated that needle recapping is permissible so long as some type of recapping device is utilized to aid in the recapping procedure, it is apparent that attempts by medical personnel to recap a used piercing element sometimes carries the risk of inadvertent puncture or touch contact, owing in great part to the exigencies and great stresses of the working environments in which practitioners use the devices.
One proposal for a recapping device requires the device to be held in one hand (with the sheath held in the device) while the needle is held in the other hand for insertion into the sheath. While such a device may be effective in reducing the risk of accidental needle sticks, it suffers a significant drawback because it requires two hands to use. Once a user picks up the handle portion with one hand, the handle is unsterile by any contaminant on the user's hand. When someone else picks up the device, his/her hand is immediately contaminated by any residue from the previous user's hand.
The medical device industry has further responded to the problem by producing a wide variety of sharps collectors, needle shielding devices and the like to assist practitioners in their need to reduce the occurrence of needle injuries. Many devices have also been developed for shielding needles after use to avoid exposing other workers to used needles. A representative listing of many of these devices is found in U.S. Pat. No. 4,982,842 to Hollister et al. Hollister et al. lists 90 U.S. patents of various devices for guarding a needle as part of the background for the present shielded needle container. Hollister et al. discloses a stand alone adapter that has a male and female end for mating with a needle assembly and the ejection end of a syringe. The device of Hollister et al. includes a housing mounted to the adapter which may be pivoted to a position in alignment with the needle for enveloping the needle and locking the needle to retain it in the housing. The Hollister et al. device increases the unusable or "dead" volume of the device on which the adapter is mounted, requires an additional part which increases the projection of the needle hub, and the mechanism for holding the cap onto the needle snaps onto the needle itself, which may create an aerosol of any fluid remaining on the needle. Also, if bevel position is important to the intended use of the needle, the Hollister et al. invention must be carefully aligned with the needle point when mounted.
U.S. Pat. No. 5,207,653 to Janjua et al. discloses a needle cap with a longitudinal slit having a width greater than the width of a needle. According to Janjua et al., the needle cap is adapted to be pivotally connected with the needle and hub piece. Janjua et al. also discloses that the needle cap is usable with a syringe or with a needle holder for fluid collection tubes. The device disclosed by Janjua et al. mounts on the needle hub with a pivot, but since it only pivots in one plane, unless the needle point is precisely with the hub oriented during assembly, the shield may interfere in some applications.
Many of the devices listed in the background of the Hollister et al. patent, the Hollister et al. invention itself and the Janjua et al. invention all attempt to address the recognized need to protect medical and service personnel from needle sticks. There are several recurrent problems in varying degrees with all these devices. Many of the devices are somewhat complex, hence are significantly more costly than an unprotected device. Many of the devices increase the complexity or increase the difficulty of performing a procedure. Some devices are so specific that they preclude use of the device in certain procedures. For these and similar reasons most of the devices in the Hollister et al. background have never been successfully commercialized.
Blood drawing is one application that is particularly sensitive to needle point orientation. Most phlebotomists carefully align a needle point with the beveled face away from the skin so that the needle point placement may be precisely controlled. A needle assembly as disclosed in Janjua et al. would either sometimes be clumsy to use because the shield would sometimes be in the way or, alternatively, more expensive because of the need to carefully orient the point during manufacture. Additionally, in Janjua et al., while there is a recognition of the need to secure the cap in the closed position over the needle, all of the solutions proposed require additional steps such as securing the cap with an adhesive or twisting the cap.
There is a need, therefore, for a way to protect a used piercing element from inadvertent touch contact and to provide a safe, reliable way to dispose of the used piercing element so as to address the problems noted hereinabove. Although there already are many shielded needle devices, there is still a need for a shielded needle device that is easily manufactured, applicable to many devices and simple to use. Additionally, the needle device should not interfere with normal practices of use.